Nutricia International Private Limited - Protinex

Recommendation: Upheld | Medium: Industry Member

The nature of Complaint: Nutrucia International Private Limited ("Nutmcia") published an advertisement for their product "Protinex Health Supplement And Nutritional Proteins Mix For Adults" ('the Product"). The advertisement showed nutrients- protein and calcium entering bones and muscles and calls out - Scientifically Designed Protinex improves strength in 8 weeks. Further the "Strength" here bas not been qualified by the Advertiser, and alongside the image of muscles and bones would clearly indicate Muscle and Bone Strength. Additionally, the claim "Protinex hai to mumkin bai" has been over exaggerated, since the claim shows a direct co-relation between the possibility of undertaking a multitude of tasks (almost anything) and Protinex. Hindustan Unilever Limited lodged a complaint against this advertisement with ASCI. Cognizance of which was taken on the ground that prima facie the advertisement could potentially violate Chapter I of the ASCI Code, ASCI Guidelines on Advertising of Foods & Beverages (F&B) and ASCI Guidelines for disclaimers made in supporting, limiting or explaining claims made in advertisements. ASCI then sought a response from the advertiser. The clain1 objected to (1) Improves Strength in 8 weeks and (2) Protinex hai to mumkin hai. The claim made "Improves Strength in 8 Week" as seen in the advertisement clearly falls within the scope of Product Claims under the Food Safety and Standards (Advertising and Claims) Regulations, 2018 ("'FSS Claims Regulations). Regulation 7(5): "Where a claimed health benefit is attributed directly to the product, it shall be based on statistically significant results from well-designed human intervention studies, conducted by or under guidance of established research institutions, in line with the principles of GCP (Good Clinical Practices) and peer reviewed or published in a peer revieli:ed reputed scientific journal." The Advertiser has failed to cite a relevant clinical study substantiating the product claim as above. Though the Advertiser has provided a cryptic disclaimer as "Protinex clinically proven to increase muscle mass in 8 weeks. Data on file" alongside a Clinical Study reference, the study so cited does not substantiate theclaim. While we gathered details of the publication referred to as "Data on file", (Document B), the san1e also does not support the e>..1ensive claim of "Improve Strength in 8 weeks". Though the clinical study shows that having Protinex as directed in the clinical improves muscle mass, it does not show any statistical change in strength (both muscle and bones as shown in the ad) as claimed by the Advertiser. In fact, in absence of clinical proof, the Advertiser has, with malice, attempted to bridge muscle mass from their Clinical with muscle strength and power mentioned in another non-product related generic scientific study. This is not only a gross eJ\.1:rapolation but a clear attempt by the Advertiser to flout both FSSAI Regulations and ASCI Code. As regards on the subject of Objection 2, I did not hear submissions of the parties and therefore, I am inclined to keep Objection 2 aside. The advertisers in response to the objection mentioned above, stated that the objection was incorrect as the claim made by the advertisers was based on the research article titled "The Effect of 8-Week Protein Supplementation with a Simple Exercise Program on Body Composition, Muscle Strength, and Amino Acid OMICS among Healthy Sedentary Indians: A Randomized, Double-Blind, Placebo-Controlled Trial" by Sucharita Sambashivaiah, Madhavi Marathe, Rohini Bhadra, Shinjini Bhattacharya, and Surnitra Selvam, published in Wiley Journal of Nutrition and Metabolism, Volume 2024, Article ID 5582234. The advertiser further mentioned that the said article was published in a "peer-reviewed journal". The clinical trial was conducted with 82 participants. The objective of this study was to evaluate the impact of 12 g of additional protein in the form of a protein supplement compared to a placebo, combined with a simple exercise program on plasma amino acid level, body composition, and muscle strength among healthy Indian adults having a relatively sedentary lifestyle. This was a double-blind randomized controlled trial. Out of 82 randomized participants, 58 completed the intervention. Blood tests were conducted for the amino acid OMICS measurement followed by dual-energy X-ray absorptiometry (DXA) for body composition and isokinetic dynamometry for muscle strength. A significant improvement \Vas observed in the lean mass (kg) and appendicular muscle mass (AMM) adjusted for weight in the intervention group compared to the control group (p<0.05). The muscle strength and contractile quality were comparable in the 2 groups, with the Protinex group showing directional improvement in muscle strength compared to placebo group. Furthem1ore, Plasma BCAA showed a significant negative association with body fat % and a positive association with lean body mass %. In conclusion, this study highlighted the value of incorporating a lifestyle intervention including protein supplementation with simple exercises to optimize body composition in sedentary healthy individuals. _7 The advertiser asserted that muscle mass and muscle strength are correlated as and refuted the Complainant's case that though clinical study showed improvement in muscle mass, it did not show any statistical change in strength of muscles and bones. 8_ ASCI referred the case to an Expert Dr. Shoven Ganguly. He opined that the Claim made in the Advertisement "Improves the Strength in 8 Weeks" was not substantiated. The Expert made following additional comments: Strongly worded product claim based on a well-designed clinical trial with "muscle strength and contractile quality" one of the primary measurable outcomes in conjunction with "lean muscle mass". Although the lean mass increased significantly in "protinex+exercise" vs Placebo (only exercise) there was only directional improvement in muscle strength and the discussion section of the paper hypothesised that e:xi:ended duration of trial ,vould have shown positive results compared to the eight weeks trials conducted. Noted the fact that there is a link between muscle mass and strength as shown in the supporting papers, but it is well proven there are several other factors which contributes to strength which is activated by exercise alone. Based on this the claim based on "muscle mass increase" is more appropriate rather than Improved Strength in 8 weeks which is not supported by clinical data using the product. However, the expert revisited the additional data provided by the advertiser and post the call with the advertiser, the expert opined that the claim is without any superlative claim and in line with a well-designed clinical study with a very rigorous measurement of muscle strength. While the improvement was a directional improvement, the results showed the improvement in muscle strength in Protinex supplemented group was higher compared to control. The advertiser also provided an extensive literature that supported the claim that Muscle mass has positive correlation with muscle strength in number of clinical studies and the same has been deliberated by the Consumer Complaints Council below. The case was then referred to for hearing before the Consumer Complaints Council ("CCC") at their meeting held in February 2025. Upon hearing both the sides and after considering the expert's opinion, the CCC recorded its findings on the claim improves the strengths in 8 week as under: "Improves Strength in 8 Weeks" - The CCC observed that the said claim in the advertisement is supported by the research article titled, 'The Effect of 8-Week Protein Supplementation with a Simple Exercise Program on Body Composition, Muscle Strength, and Amino Acid OMICS among Healthy Sedentary Indians: A Randomized, Double-Blind, Placebo-Controlled Trial', published in a peer-reviewed journal. This study provides scientific evidence for the effects of protein supplementation combined with exercise on body composition and muscle strength. The CCC discussed that the study done to evaluate the effects of protein supplementation combined with a simple exercise program on various health parameters in sedentary Indian adults. The key findings indicated that the group receiving the protein supplement (Protinex) showed significant improvement in lean mass and appendicular muscle mass compared to the placebo group. While muscle strength and contractile quality were comparable between the two groups, the protein supplement group exhibited a slight directional improvement in muscle strength. The key finding was the significant increase in lean muscle mass in the group that took the protein supplement after the intervention. The literature references provided supports the claim that muscle mass is positively correlated with muscle strength, as evidenced by numerous clinical studies. The CCC further discussed that the advertisement emphasizes that an active lifestyle combined with protein supplementation, like Protinex, can positively benefit the body. The advertisement on Amazon has a disclaimer that'Protinex should be consumed as a part of a well-balanced diet and healthy lifestyle'. The claim is presented without using superlative terms. It suggests that, with regular consumption over an 8-week period, Protinex can contribute to improvements in muscle strength. Based on this assessment, the CCC concluded that the claim, "Improves Strength in 8 Weeks", was substantiated. The said claim is not in contravention of Chapter I of the ASCI Code. This complaint was NOT UPHELD. Aggrieved by the findings recorded by the CCC, the Complainant sought Independent Review Process. The case was referred to me. I heard submissions of both the sides. I also went through the documents submitted before me. I have already mentioned above that the main dispute between the parties is about the claim "Improves Strength in 8 Weeks". The parties made submissions only on this claim. Gist of the Complainant's submissions: The clinical study made by the advertiser only indicated that there was improvement in muscle mass, but the study did not indicate significant improvement in muscle strength. Therefore, the claim that improvement in strength in 8 weeks is false and unsubstantiated. It is also submitted that muscle mass improvement cannot be equivalent to muscle strength improvement. The Complainant placed reliance on Regulation 7(5) of the Food Safety and Standards (Advertising and Claims) Regulations, 2018 (FSSAI Regulation) for product claims alongside ASCI Guidelines on F&B, which states: Regulation 7(5): ''Where a claimed health benefit is attributed directly to the product, it shall be based on statistically significant results from well-designed human intervention studies, conducted by or under guidance of established research institutions, in line with the principles of GCP (Good Clinical Practices) and peer reviewed or published in a peer reviewed reputed scientific journal." Guideline 2, ASCI Guidelines on Advertising of Foods & Beverages (F&B): Advertisements that include what consumer, acting reasonably, might interpret as health or nutritional claims shall be supported by appropriate scientific evidence and meeting the requirement of basic Food Standards laid down under the Food Safety Standards Act and Rules, wherever applicable. They argued having regard to the above provisions, it is clear that the claim did not fulfill requirements of a product claim. They also argued that there is no co-relation between muscle mass improvement and muscle strength in1provement. On this point they tried to show me an article on scientific study, but I am not inclined to look into it because this article was not before the CCC. In any case, it is not in doubt that improvement in muscle mass would necessarily improve muscle strength. There are various other physiological factors which would increase strength in muscles. They however, attack the clinical study, its data and its conclusion. They pointed out that the clinical study which was of a short duration could only indicate that the participants who consun1ed the product gained muscle mass, but there was no significant or statistical improvement in strength of muscle. The scientific study indicated that there was only directional improvement in muscle strength and further mentioned that eA1:ended duration of trial would have shown positive results compared to 8 weeks trial conducted. As against this, the advertisers tried to justify the claim on the basis of the scientific study and its results. They tried to show me Table No.I of the Report which recorded data in respect of change in body composition, muscle strength and muscle quality across groups (who participated in the test). They admitted that the data relating to the muscle strength is not significant. The question before me is whether the claim satisfies the provisions of Regulation 7(5) of the Food Safety and Standards (Advertising and Claims) Regulations, 2018 (FSSAI Regulation) for product claims alongside ASCI Guidelines on F&B? The answer to this question is in the negative. The relevant provision is quoted below: "Where a claimed health benefit is attributed directly to the product, it shall be based on statistically significant results from well-designed human intervention studies, conducted by or under guidance of established research institutions, in line with the principles of GCP (Good Clinical Practices) and peer reviewed or published in a peer reviewed reputed scientific journal." There is no dispute that the advertiser made claim about a health benefit which they attributed directly to the use of the product so, it was incumbent upon them to base that claim on statistically significant results from well-designed Human Intervention Studies. There is no doubt that the advertiser conducted a human intervention study under guidance of their research tean1and it can also be said that they followed the line with the principles of Good Clinical Practices ("GCP"), but the study did not show positively that there was statistically significant results about improvement in the muscle strength. They admitted in the Report that such result would be visible and can be statistically recorded if the study could continue for a longer duration. They simply stated that if they could prove that the use of the product improved the muscle mass, they could guess that such improvement in muscle mass would automatically improve the muscle strength. As said above, these two aspects are certainly co-related but not directly related. The expert opined "noted the fact that there is a link between muscle mass and strength as shown in the supporting papers, but it is well proven that there are several other factors which contributes to the strength which is activated by exercise alone.